NCT02983409

Brief Summary

This is an observational study based on retrospectively collected data of ureter stone patients between 2011 and 2014. Aim of study is to determine radiologic findings of non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect ureter stone patients in emergency department (ED).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
862

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

3.9 years

First QC Date

October 26, 2016

Last Update Submit

August 17, 2017

Conditions

Keywords

computerized tomographyUrinary CalculiPatient admissionPain

Outcome Measures

Primary Outcomes (3)

  • Multiple-painkiller

    Patient who take the over 2 painkiller medication because of serious pain.

    within 6 hours after the ED visit

  • Admission at ED

    Patient who admitted at the ED

    within 24 hours after the ED visit

  • Revisit to the hospital within 5 days

    Patient who revisit the hospital within 5 days after the ED discharge

    within 5 days after the ED discharge

Study Arms (1)

Pstone

Adult Patients (\> 18years) who were diagnosed as the urinary stone in the ED. All patients who visited the ED with compalin of acute pain, and urinary stone was idenfied by urinary CT in the ED.

Radiation: Pstone

Interventions

PstoneRADIATION

A adult patients who were diagnosed as urinary stone by the urinary CT

Pstone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A adult (\>18 years) patients who was diagnosed as ureter stone. They had no previous history of ureter stone within recent 1 year. They should not have a uninary congenital or acquired anomaly and chronic renal disease.

You may qualify if:

  • ED Patients
  • Age \> 18 years
  • Confirmed the ureter stone by Abdomen or Urinary CT

You may not qualify if:

  • Known a uninary congenital or acquired anomaly
  • combined other healthy preblem at the ED
  • infection, renal dysfunction et al
  • Known the chronic disease : Hypertension ,Diabetes, Tuberculosis, Malignance et al

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary CalculiEmergenciesPain

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sang O Park, Dr

    1Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 26, 2016

First Posted

December 6, 2016

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 22, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share